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Diagnosis of Bone Metastases in Breast Cancer: Bone Scintigraphy, Fluoride-PET and FDG-PET

This study is currently recruiting participants.
Verified October 2010 by Rigshospitalet, Denmark
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01224873
First received: October 19, 2010
Last updated: January 10, 2011
Last verified: October 2010
History of Changes
  Purpose

Breast cancer can metastasize to the bones, which leads to another treatment if bone metastases are detected. The purpose of the study is to determine, if fluoride PET/CT is superior to bone scintigraphy with technetium. On the other side, the investigators would like to see if FDG-PET/CT is a reliable alternative to dedicated bone imaging to detect bone metastases in patients with breast cancer.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnosis of Sceletal Metastases in c. Mammae: 18F-NaF-PET/Lowdose-CT Versus 99mTc HDP Bone Scintigraphy

Resource links provided by NLM:

Drug Information available for: Fluoride
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Estimated Enrollment: 110
Study Start Date: October 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

breast cancer patients who are treated at Rigshospitalet, DK

Criteria

Inclusion Criteria:

  • histologically proven c. mammae
  • clinically suspicion of bone metastases

Exclusion Criteria:

  • age under 18 years
  • diabetes mellitus
  • pregnancy
  • other known malignant disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224873

Contacts
Contact: Christine Winkler, Dr. christine.winkler@rh.regionh.dk

Locations
Denmark
Dep. of Nuclear Medicine & PET, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Principal Investigator: Christine Winkler, Dr.            
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Christine Winkler, Dr. Dep. of Nuclear Medicine & PET, Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Dr. Christine Winkler, Department of Nuclear Medicine & PET
ClinicalTrials.gov Identifier: NCT01224873     History of Changes
Other Study ID Numbers: H-3-2010-019
Study First Received: October 19, 2010
Last Updated: January 10, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
breast cancer
bone metastasis
comparison of diagnostic methods
 bone scintigraphy
fluoride PET/CT
FDG-PET/CT

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013